Endoscope integrity tester including context-sensitive compensation and methods of context-sensitive integrity testing

ABSTRACT

Computer systems and software for controlling an endoscope integrity tester. The pressurization and humidity measurement and calculations, and the resulting determination of passage or failure is automated and controlled to eliminate concerns of human error in the detection process. Further, the computer system is capable of adapting its calculations to specific endoscopes and particular testing changes to further improve accuracy by being context-sensitive.

CROSS REFERENCE TO RELATED APPLICATION(S)

This application is a Divisional application of U.S. patent applicationSer. No. 11/696,390, filed Apr. 4, 2007, which is a Continuation-in-Part(CIP) of U.S. patent application Ser. No. 11/371,109, filed Mar. 8, 2007and now abandoned, which is in turn a Continuation-in-Part (CIP) of U.S.patent application Ser. No. 11/123,335 and U.S. patent application Ser.No. 11/123,336, both of which were filed May 6, 2005 and now abandoned.The entire disclosures of all the above documents are hereinincorporated by reference.

BACKGROUND

1. Field of the Invention

This disclosure relates to the field of integrity testing forendoscopes, in particular to computer systems and software to carry outsuch integrity testing.

2. Description of the Related Art

As medical science has advanced, it has recognized that the ability ofdiagnostic evaluation procedures to detect various maladies early intheir development provides one of the primary tools in preventingadverse outcomes. At the same time, highly invasive procedures, even ifeffective at their intended task, introduce their own dangers. Invasiveprocedures require a long time to heal, are expensive, and can result inadditional costs due to extensive hospitalization, additional therapiesto recuperate, and lost productive time. In an attempt to provide formedical services at reasonable cost to most of the population, it isdesirable to have maladies detected, and treated early and to provideboth the detection and intervention using procedures which are asminimally invasive as possible to speed up recovery time and reducerisks introduced from the performance of the procedure.

To provide for many minimally invasive procedures, medicine has seen adramatic rise in the use of endoscopic instruments. Traditionally,extensive invasion of the body was required to allow a surgeon to seewhere he was working as well as to allow the body to admit his hands,which are relatively large instruments, during a procedure. The use ofendoscopes provides for an alternative solution in both cases.Endoscopes are long slender medical instruments which can be insertedthrough a relatively small orifice in the body. With advanced optics, anendoscope can allow a doctor to see structures without the need forinvasive surgery and often better than his normal eyesight would permit.Further, by including specially designed and small-sized instruments, adoctor's hands need not be admitted into the body of the patient toperform procedures which allows for still further reductions in the needfor large entry points. Endoscopic surgical tools have advanced greatlyin recent years allowing a doctor to examine internal structures, takebiopsies, and even perform some types of surgery. While many endoscopicprocedures utilize one or more small incisions, others utilize naturalbody openings such as the mouth, nose, ear, rectum, vagina, or urethra.The latter type of endoscopes are particularly useful when related todisease of the gastrointestinal tract or reproductive system and becausethey are inserted in naturally occurring openings, are considered to beminimally invasive.

An endoscope is generally used in a procedure by being inserted into theopening (whether natural or artificial) by a doctor trained in its use.The endoscope is then guided to the area to be examined through the useof an external control on the end of the endoscope remaining outside thebody. In some cases, such as when the colon is being examined, the pathtaken by the endoscope is itself evaluated. In some alternative cases,the endoscope is maneuvered to reach a particular destination which isto be examined or operated on. In either case, to facilitate themovement of the endoscope, the endoscope is generally a long flexibletube sized and shaped for the particular procedure to be performed andwill be capable of being guided through body structures, without damage,through what is often a convoluted path.

The endoscope will include instruments related to its function and theparticular procedure being performed. These instruments will generallyfirst provide for visual or other detection apparatus and related imagerecordation. These instruments will serve first to allow the operator toguide the instrument, but also to provide records of what was done andto store particular images for later evaluation. The tube may alsoinclude ports on the portion external to the body which allow formedications, water, air, or instruments to be inserted externally andpassed through the endoscope to the point where the internal end of theendoscope is located. The instruments can then extend from the internalend of the endoscope to allow for the performance of medical activities.These instruments will generally be controlled externally while whatthey are doing is monitored using the detection apparatuses. Endoscopeprocedures may include, but are not limited to, biopsies of material;the introduction of medical agents, irrigation water, or apparatuses;cleaning of an area for improved visual characteristics; and somesurgical procedures.

In most endoscopes, either the natural orifice through which it isinserted defines a maximum size of the scope, or the scope is generallydesired to be as small as possible to minimize the size of an incisionnecessary to insert it. At the same time, it is necessary for theendoscopes to include control mechanisms outside the body, as well asgenerally sophisticated cameras or other imaging apparatus, and portsfor, or inclusion of, medical application delivery devices. Further,electronics and systems to allow for signals to be transported from thecontrol device outside the body to the tip of the endoscope which isinaccessible inside the body are necessary. Hook-ups to externalcomputers to provide for interpretation of data signals are alsogenerally required. All of these sophisticated systems make endoscopesquite expensive and sophisticated devices. Further, the popularity ofendoscopic procedures means that most medical providers need arelatively large number of endoscopes, even of similar type, in order tobe able to provide for all the procedures they are used for.

Even while use of endoscopic instruments is minimally invasive, withoutproper care, they can still transmit disease. It is necessary thatendoscopes be well cleaned and sterilized after each use to preventtransfer of potentially dangerous agents between patients. Endoscopeswill also often operate in what can be considered a wet environment orother environment where body fluids are in contact with the exterior ofthe endoscope which is generally a form of rubber tubing. Cleaning andsterilization systems also often utilize liquids in cleaning. Because anendoscope's sophisticated design uses a high number of components whichcan be adversely effected by moisture, generally an endoscope will besealed from external fluid invasion by having its components sealedinside the flexible plastic or rubber sleeve. Components which are notsealed during use are alternatively sealed by caps during cleaning asthe entire instrument can be inserted in liquid during the cleaningprocess.

The plastic or rubber sleeve can fail over time and develop holes orfractures from repeated use and general wear and tear. Further, improperhandling or use of the scope can damage the sleeve. If the sleevedevelops holes, cracks or other points of failure, it can allow theintroduction of moisture to the internal components of the endoscope. Ifthis occurs inside the body of a patient, it may allow microorganisms totravel with the endoscope. More commonly, however, the failure willallow for cleaning agents to get inside the endoscope. Any of theseintrusions to the endoscope can be dangerous to the endoscope. Even asingle drop of water inside the endoscope can result in sensitiveelectronic devices becoming damaged and the endoscope becoming unusable.Further, the intrusion of even a small amount of body fluid can resultin a non-sterile instrument.

Beyond the possibility of fluid intrusion from cracks or breaks in thecoating, most endoscopes are required to have some access to internalstructures to allow for external devices, such as computers, to operatein connection to the internal components. In use, these ports aregenerally plugged by a connector or similar device. After use, a sealercap or related device is generally placed in the ports to seal them fromexternal invasion. These caps can also develop holes, seals can breakdown, or protective covers may be incorrectly installed. Any of thesesituations can also lead to fluid invasion of the endoscope.

To clean endoscopes between procedures, generally the endoscope is firstdisconnected from associated computer apparatus, is wiped down and openchannels are suctioned and washed to remove most of the material on thescope. The scope is then sent to be cleaned. As cleaning requiresspecific immersion or saturation of the endoscope with liquid materials,it is important that the scope be checked for leaks prior to thiscleaning; otherwise a leak could admit cleaning materials and damage theendoscope. Traditionally, leaks were tested for by a technician whowould access the internal structure of the endoscope, and if a leak wasdetected, connect an air source and introduce air to raise the internalpressure of the scope above the ambient to inhibit fluid invasion duringcleaning and prior to repair.

In the most basic test methodology, the scope was immersed in fluid(usually water) while held at a positive pressure and left there for aperiod of time. During this time, the technician would look for bubblesrising from the endoscope indicating loss of air from the internalstructure. This methodology was fraught with problems. In the firstinstance, placing the structure in water tended to produce bubbles.Further, solutions used to initially clean the endoscope couldthemselves create bubbles when interacting with the water. Stillfinally, movement of the scope in the water could conceal or introducebubbles.

To try and get around this problem, systems were introduced whichallowed the internal area of the endoscope to be pumped to a particularpressure. The user would then watch a gauge or indicator to determine ifthe pressure decreased over a period of time. Other systems tried toautomate the provision of air, and the monitoring of pressure. One suchsystem is described in U.S. Pat. No. 6,408,682, the entire disclosure ofwhich is herein incorporated by reference.

Integrity testers for endoscopes which rely on purely human control todetermine if a leak exists are fraught with problems. The human userwould pump up the internal area of the endoscope to about the desiredpressure, but pumps could be unreliable and gauges may not actuallyindicate true pressure. The user then reviewed what was usually ananalog gauge for any movement of the needle downward indicative of aleak. While fairly large leaks were readily noticeable, smaller leaksmay not be noticed as the ability to notice them would be dependent bothon the user's ability to read a gauge, which could have a large amountof wiggle, and the willingness of the user to watch the gauge longenough to make sure that any loss is detected.

Automated systems generally were not much better. While these systemsallowed for machine monitoring of the internal pressure which allowedfor more accurate calculation, the systems generally relied on volumechanges which are inaccurate due to the rubbery nature of the sleevematerial. Further, the systems did not provide for processor controlrelated to humidity testing in addition to pressure testing.

SUMMARY

Because of these and other problems in the art, described herein, amongother things, are computer systems and software for controlling anendoscope integrity tester. The pressurization and measurementcalculations and the resulting determination of passage or failure isautomated and controlled by a computer control system to eliminateconcerns of human error in the detection process. Further, the computercontrol system is capable of adapting its calculations to specificendoscopes and particular conditions of testing to further improveaccuracy.

Described herein, among other things, is a method for testing theintegrity of an endoscope, the method comprising: obtaining anendoscope; supplying gas to an air enclosure which includes an internalvolume of the endoscope to pressurize the air enclosure; sealing the airenclosure; measuring the pressure of the gas in the air enclosure overtime; detecting an first rate of decrease in air pressure; recognizing asecond rate of decrease in air pressure, the second rate being less thanthe first rate; discarding the first rate; and comparing the second rateto a predetermined target rate to determine if the second rate issufficiently high to indicate a leak in the endoscope.

In an embodiment, the method further comprises: instructing a user tomanipulate the endoscope while the air enclosure is pressurized such as,but not limited to instructing manipulation of endoscope buttons orknobs which causes movement of endoscope tubing.

In an embodiment of the method the predetermined target rate is storedin a computer memory. In another embodiment, in the measuring, thepressure of the gas is at least 4 lbf/in².

In an embodiment, the method further comprises: identifying theendoscope as having been tested previously. The predetermined targetrate may then be determined based on at least one previous test of theendoscope.

In a still further embodiment, the method further comprises: placing theendoscope in a holding device, which may comprise a holding bin having amat on its base, the mat including a plurality of fingers, prior to thestep of measuring.

There is also described herein a method for testing the integrity of anendoscope comprising the steps of: obtaining an endoscope to be tested;retrieving a plurality of calibrating humidity values from a pluralityof prior endoscope tests from a memory; obtaining an environmentalhumidity value from air external to the endoscope to be tested;manipulating at least a portion of the combination of the plurality ofcalibrating humidity values and the environmental value to produce atarget humidity value; supplying a gas to an air enclosure whichincludes an internal volume of the endoscope to be tested; venting thegas in the air enclosure to a humidity detector; determining the levelof humidity in the vented gas; and comparing the level of humidity tothe target humidity value to determine if the level of humidity in theendoscope is sufficiently high to indicate fluid invasion into theendoscope to be tested.

In an embodiment of the method, in the retrieving, the plurality ofprior tests do not include a prior test of the endoscope to be testedwhile in an alternative embodiment, the plurality of prior tests onlyinclude prior tests of the endoscope to be tested.

In an embodiment of the method, in the manipulating, an average ofcalibrating humidity values is determined. This may be a weightedaverage of calibrating humidity values is determined using theenvironmental humidity value as the weighting factor or anothercalculated average.

There is also described herein, a computer implemented method forperforming endoscope integrity testing, the method comprising: providingto a computer controlled endoscope tester an endoscope to be tested; thetester identifying the endoscope as having been tested previously; thetester retrieving from a memory, a retrieved value of property of airdetermined from at least one prior test of the endoscope; the testertesting the endoscope by supplying air into an internal enclosure of theendoscope; the tester determining a current value of the property of airfrom the air supplied into the internal enclosure of the endoscope; thetester comparing the current value to the retrieved value; the testerdetermining if the comparison indicates a compromise of integrity in theendoscope; and the tester supplying the determination to a user.

In an embodiment of the method the retrieved value is an average of allprior tests of the endoscope or the property of air is pressure orhumidity. In another embodiment of the method the identifying includes,identifying a serial number associated with the endoscope.

In another embodiment the method further comprises: recording thecurrent value.

There is also described herein, a computer system for testingendoscopes, the system comprising: at least one sensing means; memorymeans; and processing means coupled to the sensing means and the memorymeans; the processing means being capable of: identifying an endoscopeto be tested as having been tested previously; retrieving from thememory, a retrieved value of a property of air determined from at leastone prior test of the endoscope; testing the endoscope by supplying airinto an internal enclosure of the endoscope; determining a current valueof the property of air from the air supplied into the internal enclosureof the endoscope; comparing the current value to the retrieved value;determining if the comparison indicates a compromise of integrity in theendoscope; and supplying the determination to a user.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a front prospective view of an embodiment of a device fortesting the integrity of endoscopes.

FIG. 2 shows a block diagram of a computer control system.

FIG. 3 shows a flowchart of the steps in one method of operation. Theprocess is divided between FIG. 3A and FIG. 3B.

FIG. 4 shows an embodiment of a printout of results from an endoscopetest.

FIG. 5 shows three graphs of representative pressure loss curves whichcan indicate loss or maintenance of integrity.

FIG. 6 provides a flowchart showing how to get a compensating humiditytarget.

FIG. 7 provides a flowchart showing how to have scopes be remembered bythe testing apparatus for future testing compensation.

DESCRIPTION OF PREFERRED EMBODIMENT(S)

FIG. 1 depicts an embodiment of an integrity tester (10) for use todetermine the integrity of endoscopes (901). That is, to determine ifthe internal area is sealed or if there are openings which could allowfluid invasion. This particular embodiment of integrity tester (10) isdescribed in additional detail in U.S. patent applications Ser. Nos.11/123,335 and 11/123,336 which are parents of this instant case andincorporated herein by reference. This is not the only type of integritytester that the computer control systems (301) discussed herein mayoperate on, but merely provides an exemplary embodiment.

Without going into great detail as to the operation of an integritytester (10), the integrity tester (10) will generally perform at leastone of a pressure measurement or humidity measurement on the endoscope(901). Pressure measurements will generally involve pressurizing theinternal space inside the endoscope (901) (generally along with someexternal space to form a single area called an “air enclosure”) to testfor leaks of pressurized air outwards. Humidity testing, on the otherhand, utilizes the possibility of wetness (along with exterior air)being pulled into a leaky endoscope (901), or already being presentinside a leaky endoscope (901) as an alternative test for leaks and atest for potentially damaging conditions.

Generally, the integrity tester (10) comprises a housing (100), whichwill serve to house the various components. Generally, the componentswill include the computer control system (301), an air compressor orother air source, a pressure sensor, and a humidity sensor. There willalso be a series of valves which allow for air to flow into or out ofthe endoscope and to form an air enclosure, which includes the internalstructure of the endoscope. The air enclosure, therefore, is designed tobe a predefined volume including the internal space of the endoscope(901). In this way air pressure within the endoscope (901) can bemonitored without placing a pressure sensor physically within the sleeve(903).

The endoscope (901) is attached to the tester (10) for testing. Theintegrity tester (10) of FIG. 1 is designed to test both pressure andhumidity tests and the discussions herein will focus on computer controlsystems (301) for performing a pressure test followed by a humiditytest, however one would understand how to utilize this teaching toperform one or the other test alone or to alter the order in which testsare performed.

The tester (10) of FIG. 1 will generally be controlled by a computercontrol system (301) which is intended to provide for automated controlof the pressurization and testing of the endoscope (901), and theevaluation of output of the pressure and humidity sensors to determineif there is a leak in the endoscope (901). The computer control systemis preferably capable of adapting its calculations to specificendoscopes or particular conditions of testing to further improveaccuracy. In this way, the testing is context-sensitive in that thecomputer control system (301) can measure each endoscope in a context ofprior endoscope (901) measurements. This context may be priormeasurements of the same endoscope (901), such as to allow forcompensation of a particular endoscope's (901) peculiarities, or may bein the context of multiple endoscopes (901), such as to detect shiftsover time of environmental testing conditions.

An embodiment of a control system (301) is shown in block diagram inFIG. 2. The computer control system (301) will generally comprise aprocessor (303) which will perform calculations and manipulations on thevarious data provided to it as well as generally instruct othercomponents. This may include sending or receiving signals to or fromthose other components. The processor (303) may be of any type known tothose of ordinary skill in the art and may, in an embodiment, comprise ageneral purpose processor (303) running software programs provided in anattached primary memory (305), or may comprise a single purposeprocessor (303) specifically programmed or built to control theintegrity tester (10).

The computer control system (301) will also include an interactionsystem (401) which generally includes a data input device (411) and adata output device (413). The data input device (411) can comprise anumerical keypad, keyboard, buttons, switches or other structures whichcan be manipulated by a user so the user can provide input into thecomputer control system (301). In an embodiment, data input can also beobtained from a microphone or other audio source, or other type ofdevice. The data output device (413) will generally be any form ofdisplay (403) known to those of ordinary skill in the art for providinginformation from the computer control system (301) to the user. Thisinformation may comprise results of tests or other output of theprocessor (303), or requests for information from the user, or othertypes of information. In an embodiment, the display (403) will comprisea screen such as, but not limited to, an LCD screen capable of providinga visual indicator of information through the use of standard charactersor symbols. The display (403) may also include indicators or lightswhich serve as alternative visual indicators. The display (403) may alsoadditionally or alternatively comprise devices capable of generatingaudible or other non-visual signals.

The computer control system (301) also includes a pressure sensor (321)and humidity sensor (323) which are capable of generating signalsindicative of current air pressure and current air humidity in the airenclosure. In the depicted embodiment, these devices generate analogsignals and therefore the computer control system (301) also includesanalog to digital converters (308) to provide the data output from thesesensors in a manner that is understood by the processor (303).

The computer control system (301) will also include associated primarymemory (305) which is used for operations during the testing. In anembodiment the memory will include computer software providinginstruments for the operation of the processor (303). The primary memory(305) may also be used for the storage of testing parameters orvariables which are used by the computer control system (301) fortesting the endoscope (901). The primary memory may also be used forstorage of processor (313) output.

In another embodiment, there is also included a secondary memory (307)which can be used to both store testing software or variables for use bythe processor (303) and which can also be used for storage ofinformation generated by the processor (303). Often the secondary memory(307) will provide for storage of test results for later retrieval. Inan embodiment, the secondary memory (307) may be designed to beremovable so that information can be transferred from one tester (10) toanother tester (10) or an alternative device. Generally, when thisdisclosure refers to reading or writing a value to memory either primarymemory (305) or secondary memory (307) could be used, if present.

The computer control system (301) may also include systems forconnecting other computing devices to the tester (10), both via networksor by direct connection. This can allow for external memory devices,diagnostic tools, programming devices, input or output devices, or otherdevices to be temporarily or semi-permanently attached to the tester(10). In an embodiment, this is done to allow for multiple testers (10)to operate together in a network fashion. In such an embodiment,elements of the computer control system (301) may be provided as networkresources (e.g. a central processor or memory may be shared by alltesters) to provide for improved computational performance and decreaseddowntime.

The computer control system (301) also includes a hard copy generationdevice (181) such as a paper printer which is used in addition to thedata output device (413) which is intended for providing more transientoutput. The computer control system (301) will also generally includesome form of clock circuit (309) to provide for both traditional dateand time information along with clock signals to time testing activitiesand a power input source (391) and possibly power regulator (393) asshown.

In a preferred embodiment, the computer control system (301) will relyon computer readable code or instructions which are held in memory toprovide for its operation. In general, this software will be capable ofinstructing the various components of the tester (10) to perform stepssuch as those shown in FIG. 3 and to perform calculation on receivedvalues and tests against known testing parameters. In an alternativeembodiment, the processor (303) will be hard wired to perform thenecessary calculations. Regardless of which method is used, the computercontrol system (301) provides instructions to control operation of thecomponents of tester (10). This allows for the tester (10) to generallyperform all tests in an automated manner and to rapidly and repeatedlyperform calculations. The computer control system (301) also eliminatesa large amount of measurement error as the human element is removed frominterpreting the received results in the first instance.

The computer processing of the endoscope (901) information begins oncethe user has connected the endoscope (901) and the computer controlsystem (301) has been provided with power. One embodiment of a testingoperation is shown in FIG. 3 and some details of particular methods areshown in FIGS. 6 and 7. At the start of FIG. 3, the user will commencean interaction with the integrity tester (10) to indicate that a test isto be begun in step (801). This can be as simple as pressing a start orpower button to initiate the testing process. There may, in a firstembodiment, be a general login process (802) which occurs prior toallowing the system to commence testing. This may be desirable if thesystem is used by multiple users or is allowed to power off betweentests. The initial system login (802) may include user identificationinformation or other information that will be used for a multiple oftests before the system is powered off or otherwise placed in a standbysituation. This may be used for security purposes or for quality controlreasons, amongst other things. Once this initial login process iscompleted, the tester (10) is prepared to test endoscopes. As the tester(10) will generally rely on the user for indications of when anendoscope (901) is to be tested, the computer control system (301) willgenerally enter a standby mode until instructed that a testing cycle isdesired by the user. This indication may be provided by the userpressing a start button indicating that they wish the tester (10) tobegin the testing cycle.

Generally, after the testing cycle is initiated in step (803), thecomputer control system (301) will request, in step (808) via the dataoutput device (413), the user provide initial variables regarding thistesting cycle via the data input device (411) in step (810). Thesevariables will generally provide for information related to identifyingthis particular testing cycle and the endoscope (901) to be tested. Theuser may also provide various other indications during this initial datagathering phase.

In most cases, at least some information will be requested from the user(808) so that output can be associated with the specific endoscope (901)and testing cycle and any desired modifications to the standard testingroutine can be loaded. Often the software will request an identifier(such as a serial number or related identifier) so as to associate theinformation gathered with the particular identifier when stored foreasier searching and retrieval. In an alternative embodiment, specificsabout the type of endoscope (901) to be tested (either by entry ofidentifiers or by having the user select from options) or the hookupbeing used may be requested. These pieces of information may be used bythe processor (303) in selecting a particular set of testing parametersto be used in this testing cycle from a number of testing parameters.Alternatively, the variables may be used to compute the actual testingparameters.

In an alternative embodiment, instead of requesting information from theuser (808), the computer control system (301) may obtain the informationdirectly from the endoscope (901) by sending a query to various sensorsor other devices that can return information about the endoscope (901)as shown in step (804). This may be from electrical connections madeduring the connection of the endoscope (901), or via wirelessmechanisms. For instance, in an embodiment, the endoscope (901) canidentify itself to the tester (10) when it is connected by sending apacket of information to the processor (303) when the connection ismade.

In a still further embodiment, the processor (303) can send outadditional queries to obtain more information outside of the user orendoscope (901). For example, in an embodiment, the computer controlsystem (301) may request various data related to air collected fromwithin the endoscope (901) prior to commencing any testing to estimate atemperature within the endoscope (901), for example. Alternatively, theprocessor (303) could at this time also issue queries to gatherenvironmental information such as humidity or temperature in the room inwhich the tester (10) is located as indicated in step (806). Thisexternal request for information need not be performed before theautomated portion of the testing cycle begins but may be performed atany time during the testing alternatively or additionally.Alternatively, the processor (303) can request information from memory(305) or (307) related to the endoscope (901) to be tested as discussedlater. Any values collected in step (803) may be stored in step (814).

Once these initial variables have been received by the processor (303),the processor (303) will generally select the testing parameters in step(805). The testing parameters (812) generally are data and computationsthat will be used by the processor (303) to determine if the endoscope(901) should pass or fail any test to be performed on it. The term istherefore used herein to generally refer to the information that needsto be calculated or loaded by the processor (303) to perform the desiredtesting. This may include, but is in no way limited to, any or all ofthe following: length of time in which to perform the testing, maximumor minimum allowed values of pressure and humidity; pressure to be usedto commence testing, or expected values of pressure and humidity overtime-based criteria. The selection of testing parameters (812) maycomprise the processor (303) performing mathematical calculations usingthe variables and various preset stored values to determine theparameters of the analysis, or may comprise loading of a profile ofprepared values to test the endoscope (901) against. Such profiles willgenerally comprise a set a testing parameters to be used, or of valueswhich are used to generate the testing parameters, depending on the typeof endoscope (901) being tested and the desired tests to be performed.

Different endoscopes (901) can have different parameters. The processor(303) may also take into account environmental or other conditions. Forinstance, certain endoscopes (901) may require more air to inflate, maynaturally lose more air through their fittings, or may react differentlyto temperature. By selecting parameters of expected performance, thetester (10) can attempt to minimize error in the testing process. Ineffect, the processor (303) determines the testing parameters that aremost likely to indicate that this endoscope (901) either does or doesnot have a leak based on the variables measured during the testingcycle. For instance, if a larger stronger endoscope (901) is beingtested, the computer control system (301) may inflate the endoscope(901) to a greater pressure than if a small, easily damaged, endoscope(901) is being tested. Further, an endoscope (901) which is hot may beallowed to have a longer stabilization period, or an endoscope tested ina wetter climate may be allowed to include higher natural humidity.

In an embodiment, the profile of testing parameters may be specificallybased on prior performance of the same endoscope (901) in the same testsand therefore its expected performance in this test if there has notbeen any change to it. These prior results may be used directly asparameters, or a number of them may be mathematically manipulated toform the parameters. Such manipulation may include, but is not limitedto, calculating average and standard deviation. An embodiment of aflowchart showing a test utilizing parameters based on prior performanceof the same endoscope (901) is provided in FIG. 7. In this embodiment oftest parameter selection, the step of obtaining testing parameters (805)occurs generally as follows. The processor (303) will utilize theidentifier for the particular endoscope (901) provided in step (803) anddetermine if the endoscope (901) has previously been tested by thistester (10) or by another tester (10) the stored data of which thistester (10) has access to in step (1801). If the endoscope (901) has notbeen tested previously, there is no past data on the endoscope (901) touse to influence the testing parameters, so the system will selectdefault parameters in step (1803). The default parameters may simply bea preset test to be performed on endoscopes (901) which have not beentested before, or may comprise a default starting point which iscombined with other inputted data to generate a specific profile forthis endoscope (901). As a previously untested endoscope (901) willoften be a new endoscope (901) this may also influence the parameterselection.

If the endoscope (901) has been tested previously, the computer controlsystem (301) will retrieve the prior test results in step (1805) frommemory (305) or (307). The prior test results may then be modified orcombined with the outside environmental variables of step (806) and anyother information available to the processor (303) to generate a scopespecific testing profile in step (1807). This scope specific profile isbasically a customized profile for the way the endoscope (901) isexpected to perform in this testing cycle based on how it has previouslyperformed in prior testing cycles weighted based on changes specific tothis cycle which may have an effect. While the use of such prior testingresults could occur in any fashion, a number of possible methodologiesshould be apparent.

In an embodiment, the tester (10) will store all the prior results ofprior tests. In the situation where all prior tests have shown theendoscope (901) to have maintained its integrity, this group of testscan provide for a floating baseline over time of the score the endoscope(901) usually obtains when passing. If the endoscope (901) in thecurrent test scores within this range, or a small deviation from it,when under similar environmental and testing conditions, this willgenerally be treated as a pass. If the testing conditions are differentor other conditions are different (for instance if the scope is muchhotter than normal), the system can provide for calculation compensationbased on the predicted value from other tests. For instance, if thescope normally stabilized in a certain range of time which is longerthan the average for scopes of this type and the scope is hotter thannormal, the processor (303) may provide for a longer stabilization timewithout triggering a potential fail situation. Alternatively, the rangeof allowed deviation from the standard may be increased in such asituation.

When using previously stored information about the same endoscope (901),the information may include any number of prior tests, averages or othermathematical computations based on a plurality of tests, or evenrecognition of changing circumstances. Further, generally the more eachendoscope (901) is tested, the more data on its performance that will beavailable and the more information which may influence the parameters.For instance, if an endoscope (901) had previously been tested 100 timeswithout failure, but failed the 101st test, upon the 102nd test, earliertest results (e.g. the first 50 tests) may be used to provide parameterson the ground that since it has been fixed, the endoscope (901) shouldbe able to meet more demanding test requirements, comparative to when itwas new as opposed to those of when it had been in long relativelycontinuous use. Had the scope have passed test 101, however, an averageof the 50 most recent test outcomes may be used in test 102 to allow forflexibility increases or other changes to the endoscope (901) which mayhave been introduced over time to weight the profile. Alternatively,specific tests performed at similar temperature and humidity conditionsto the current ones can be selected from amongst all the prior tests totry and compensate for environmental changes.

While the above specifically discusses using prior data for pressuretesting, such prior data can be used in pressure testing, humiditytesting, or both depending on the desired operational mode of thedevice. Further, the user can select different types and even differentselections of prior data to use in different embodiments of the tester(10) as opposed to the processor (303) selecting the values according tovarious criteria.

While the selection of a profile of testing parameters and/or thecomputation of testing parameters (812) based on the input variables andbased on the specific endoscope (901) is desirable in an embodiment, itis by no means required and in the simplest case the testing parameters(812) may be fixed across all endoscopes (901). In this embodiment,therefore, the testing parameters (812) would be the same in each case,however, the testing parameters (812) may or may not be altered byenvironmental readings or other variables. This embodiment is desirablewhere the system is likely to be testing only similar endoscopes (901)under similar conditions repeatedly or where there is little concern forloss of accuracy due to variance between endoscopes (901) being tested.

Once the testing parameters have been obtained by the processor (303),generally from memory, the processor (303) will next send instructionsin step (807) to an air compressor or other air source to commenceproviding air into the internal structure of the endoscope (901). Thisfilling will commence the actual testing phase of the cycle in step(807). In order to obtain a pressure as close to the target pressure(generally in the testing parameters) as possible, the processor (303)will generally continuously query a pressure sensor (815) using clocksignal (816) until the target pressure is as close as possible to thedesired pressure.

In order to improve accuracy of the pressure test, the pressure insidethe endoscope (901) is generally as high as possible, without risk ofdamage to the endoscope (901). Traditionally, pressure provided to theendoscope (901) has been limited to just a couple of pound feet persquare inch as that is all a hand pump can easily generate. Even inwater bath measurements where air compressors were used, pressuressimply above the weight of the water on the endoscope (901) (generallyaround 3 lbf/in²) were used. Higher pressures are beneficial as theyprovide for a greater degree of accuracy in endoscope (901) testing.With a higher pressure it is more likely that a hole in the endoscope(901), which may be held closed by the flexible nature of much of theendoscope (901) sleeve, will be forced open by the air pressure. Air ata higher pressure is therefore more likely to escape from a small holeheld shut by surface tension, gravity or similar forces making it morelikely that small holes are detected. Further, for a hole of equal size,the pressure internal to the endoscope (901) will often change moredramatically at a higher pressure than at a lower pressure because moreair is forced out with the higher pressure. It is usually preferred thatthe air pressure in the air enclosure and therefore in the endoscope(901) be raised to a pressure at or above 4 lbf/in² and generally lessthan 8 lbf/in² but that is by no means required. It is often preferredthat the pressure be about 4.5 lbf/in².

The particular target pressure for the endoscope (901) is generally oneof the selected testing parameters and therefore may be at least in partdetermined by the nature of the attached endoscope (901) and other inputof collected variables. In this way an endoscope (901) which can bettertolerate higher pressures may be exposed to higher pressures. Further,the target pressure can also be modified to compensate for environmentalfactors, such as the endoscope's (901) temperature, which can effect theendoscope's (901) interaction with the air by altering its potentialenergy and/or by effecting its pressure, volume, etc.

In an embodiment, the processor (303) will continuously monitor theoutput of a pressure sensor in step (807) as air is added to the airenclosure and thus the endoscope (901) in step (807). If over apre-selected window of time the air pressure has not reached the targetpressure in step (809), the processor (303) can determine that theendoscope (901) fails the pressure test in step (811) as it issufficiently leaky to be unable to pressurize. Alternatively, a failureto reach pressure could indicate a problem in a connection or adefective component. To address this situation, a retest may besuggested to the user via the data output device (413) in step (813)telling the user to disconnect and reconnect the endoscope (901) andretest.

Depending on the embodiment, if there is a failure due to an inabilityto reach target pressure, the integrity tester (10) may continue toperform the humidity test discussed below, may alter the humidity testparameters such as to perform an extended humidity test, or mayterminate the test process as the endoscope (901) has already beenfailed and requires service regardless. In the embodiment of FIG. 3, afailure to reach pressure results in storage of an impossible pressurevalue in step (814) which the processor (303) recognizes as clear fail.

In addition to determining if an endoscope (901) can reach the targetpressure, the computer control system (301), in an embodiment, maymeasure the length of time it takes to bring the endoscope (901) up topressure and/or the rate that the pressure increases. The first pressuretest may therefore involve this calculation of time to bring the airenclosure up to pressure. If it takes too long to bring the endoscope(901) up to pressure or if the rate is too low, even if the endoscope(901) can reach the target pressure in the window of time, the integritytester (10) may determine that a leak exists and fail the endoscope(901). Alternatively, the rate of pressurization may also be used by theprocessor (303) in later calculations to determine if a pressure loss isunacceptable. If the endoscope (901) takes a longer time to pressurizethan is expected and was hot, for example, the processor (303) coulddetermine that the sleeve (903) is expanding significantly and thereforeprovide for a longer wait period to allow it to stabilize. The processor(303) may also alter the testing parameters to use a lower targetpressure to prevent possible damage from deformation at a higherpressure based on such a reading.

If the endoscope (901) is able to brought up to pressure within thewindow of calculation and at a sufficient rate of speed, the integritytester (10) will begin the pressure maintenance testing to determine ifthe pressure is maintained over time. The test generally begins when theair enclosure (and thus the endoscope (901)) is sealed from knownoutside air sources or vents in step (815). Once sealed in step (815),the computer control system (301) will disable the air input andinitiate a wait cycle in step (817) to allow the air enclosure'spressure to stabilize over a period indicated by the clock signal (816)before initial pressure values are taken in step (821).

In the wait period of step (817), the system will allow for theendoscope (901) to stabilize under pressure. The endoscope (901)comprises a generally rubber or plastic sleeve (903) whose integrity forholes is to be tested. This sleeve (903) is subject to stresses from theinternal air pressure which is applied to it and may deform or expanddue to that pressure as its structure is generally not rigid. Thisdeformation is also more likely to be present if the endoscope (901) isat a warmer temperature (which it often is as it is tested after beingcleaned and/or sterilized) or if the endoscope (901) is more flexibledue to its design. Temperature can introduce a number of issues becauseas the internal air heats (absorbs heat from the sleeve (903)) the airpressure may increase, while at the same time the sleeve's (903)increased flexibility may increase the volume internal to the sleeve(903) decreasing the air pressure. The waiting period may be determinedbased on the temperature or other characteristics of the endoscope (901)that are part of the profile or may simply be a fixed preset.

The processor (303) will generally utilize the signals (816) of theclock circuit (309) to determine if the waiting period has elapsed instep (817). At the end of the waiting period, the computer controlsystem (301) will generally check to see if the pressure has beenmaintained at an acceptable level in step (819) through the waitingperiod to begin testing in step (821). If not, the computer controlsystem (301) may reactivate the air source and flow more air into theendoscope (901) or may allow pressure levels to decrease by venting someair. In another embodiment, the computer control system (301) may simplytake readings utilizing the altered starting pressure value. In effect,this initial waiting period (817) does not utilize pressure differencepresent to determine if there is a leak, but instead attempts to makesure that a false reading will not be given in later testing due toeffects present in any endoscope (901) under the particular conditions.In the event that the stabilization resulted in a need to alter theinternal air composition, there may then be an additional waiting periodto allow further stabilization, or the testing may simply continue tostep (821).

Generally, a commencement of testing activities after a single waitingperiod is preferred as it does not allow for the computer control system(301) to become stuck in a situation where a leak is interpreted asstabilization behavior. Therefore, the computer control system (301)will now record the starting pressure in step (821) sending that valueto memory in step (814). This value is generally around the targetstarting pressure based on the testing parameters. The computer controlsystem (301) will monitor the pressure by querying the pressure sensorfor readings (818) on a regular basis via step (825). Generally, thepressure will be monitored for a fixed period of time based on theoutput (816) of the clock circuit or for a fixed number of measurements.

While the pressure is maintained in the endoscope (901) by maintainingthe seal on the air enclosure, the control system (301) may periodicallyenter into hold phases during the testing and indicate that the usershould perform various manipulations on the endoscope (901). In thedepicted embodiment, a user is instructed to perform a particularmanipulation on the endoscope (901) by indications on the data outputdevice (313) in step (822). Once the user has performed themanipulation, they indicate to the computer control system (301) via theinput device that the manipulation has been performed in step (824)which indicates to the computer control system (301) to exit the holdingpattern and allow the test to continue.

In the depicted embodiment, user interaction in step (825) relates tothe user being instructed to manipulate the knobs and/or buttons of theendoscope (901). Once so instructed, the user is expected to pick up theendoscope (901) at its control portion and manipulate all the knobs,buttons, etc. of the endoscope (901). This will provide for movement ofthe endoscope (901) in all directions. The movement will help to revealtears or holes in the sleeve (903) which may only be apparent when theendoscope (901) is positioned in a particular fashion. In particular,movement will cause the rubber at the moving portion to be stretched orflexed as it may do during the course of both a procedure and cleaning.Further, it tests for leaks in seals related to manipulation controls.

The user will also generally manipulate buttons related to variousoperations of the endoscope (901). This may serve to move the endoscope(901) in the same way as the manipulation of the knobs did, butgenerally, and often more importantly, will test for any holes in thebutton seals. Once the user has completed the requested movements, theuser will indicate to the control system (401) that they have completedthe manipulation in step (824). The computer control system (301) maythen continue the test. If the user does not indicate that the endoscope(901) has been manipulated within a certain time window after theinstruction is sent, the computer control system (301) will generallytime out and indicate an error condition because the manipulation wasnot indicated to have been performed.

It should be apparent to one of ordinary skill in the art that themanipulation of buttons and knobs provides for benefits to the integritytester's (10) accuracy. In particular, in order to manipulate buttons orknobs, the endoscope (901) is moved at least once during testing, thismay provide for a hole to be revealed and allowed to open which was heldshut by the initial placement of the endoscope (901). This can occur forinstance, if the endoscope (901) principle tubing is placed so that itis coiled or where one portion overlaps another. Further, themanipulation allows for components which can be damaged by interactionwith an operator to be tested and to be tested under conditions that theendoscope (901) may experience during use or cleaning. Therefore, if ahole exists in a portion of a button cover designed to flex, but thathole is only revealed when the material is flexed, it is detected by theflexing and can be fixed before it presents a major concern. While thepictured embodiment provides that the manipulation be performed by theuser, this is by no means required and in an alternative embodimentrobotic or similar manipulation systems may alternatively be used toautomatically perform the manipulation.

Once all manipulations have been indicated to be performed, the testingwill generally continue until the time period indicated by clock signal(815) is completed or a preliminary test is determined sufficient toindicate failure during the period of step (825). This period of testingwould generally have been selected either by initial user variables oras part of the testing parameters and will generally be between one andfive minutes. The period may be calculated so that the selected lengthof the complete test includes the time of manipulation, or may beselected to count time excluding the time of the expected manipulation.

To determine if sufficient pressure is lost within the time period toindicate a leak, the computer control system (301) in step (827) may usea variety of calculation and evaluation techniques. Regardless of howwell components are sealed, there will always be some slight pressureloss due to natural bleeding of components and additional stretching ofsome components during the testing cycle. Further, handling of theendoscope (901) can alter the pressure values slightly by potentiallyaltering the internal volume during the handling. The computer controlsystem (301) will generally, therefore, have as part of the testingparameters an acceptable pressure loss for the endoscope (901). Thisacceptable value may relate to testing on known endoscopes (901) whichare known to be undamaged to determine an expected or acceptable loss ofair pressure for undamaged endoscopes (901).

In an embodiment of the pressure determination, a time pressure averageof a plurality of pressure measurements within sub periods of the timeperiod of testing are used in the calculation to compute a raw pressureloss over the time period or any sub periods. In an embodiment, noiseand other factors are removed from this determination to provide for asmoothed indication of pressure where small individual changes that arelikely caused by factors other than an actual leak are ignored oraveraged out. For instance, a slight increase in pressure may beexpected when the device is manipulated, leading to a small downwardspike when the manipulation is completed. The change in pressure overthe period of the test, or any portion of the test, is then determinedand adjusted for the measurement accuracy of the pressure sensor. Theresult is then compared against an allowed or threshold change rate instep (827). If the calculated change is greater, the endoscope (901) isfailed in step (829) as more pressure has been lost than would beexpected if the endoscope did not have a leak; if less pressure than thethreshold is lost, the endoscope (901) is passed in step (831). Thesevalues are generally reported to the user in step (826).

While raw pressure loss over time provides for one beneficial way ofmeasuring for possibly integrity problems, in an alternative embodiment,the system actually compares a rate of pressure loss over themeasurement period as opposed to a raw pressure loss. In such anembodiment, the computer control system (301) also does not use the purepressure drop for determination of acceptable or unacceptable pressurechange, but instead looks at the rate of pressure drop. This allows thesystem to recognize that the endoscope (901) will always lose somepressure and that the amount lost may actually meet a net loss target,but the rate may be sufficiently low to indicate that there is not aleak. The issue is that an endoscope (901) with a leak will losepressure faster than one which is instead simply losing pressure due tonatural pressure loss over time.

In an embodiment which measures loss rate, the computer control system(301) will look for a leveling out of the rate of loss, at a point whichis still sufficiently above the atmospheric pressure to indicate thatthe endoscope's (901) internal pressure has stabilized above theatmospheric pressure, while still showing a sufficient decrease in rateto indicate that the initial stabilization period has passed.

FIG. 5 provides for three graphs which show possible loss curves fordifferent types of scopes. In the first curve (FIG. 5A), the pressureinside the scope rapidly falls off from an inflated pressure in section(1401) which would represent the stabilization period to a pressureright around the pressure external to the scope where it levels off insection (1403). This type of curve would generally indicate a scope witha major leak which is incapable of maintaining pressure and in need ofrepair as the endoscope (901) effectively never stabilized at a pressureabove the ambient.

The curve of FIG. 5B provides for a different situation. In thissituation, the pressure rapidly falls off in section (1411) againindicating stabilization behavior but then flattens out in section(1413) at a pressure level significantly above that of the atmosphere.This decrease in rate would be the expected behavior of an endoscope(901) which has not had its integrity compromised by a hole. As shouldbe apparent from FIG. 5B, there is still pressure loss in section (1413)as indicated by the continuing downward slope, but the rate issufficiently low (the slope is sufficiently horizontal) to imply thatthe continued pressure loss is not due to a hole. In FIG. 5B theendoscope (901) cannot necessarily maintain the initial pressure andneeds to adjust, but once an equilibrium point is reached, the rate ofloss of pressure decreases sharply, and while the endoscope (901) isstill losing pressure, it is losing it at a much decreased rate.

This is contrasted with FIG. 5C which provides for the case of anendoscope (901) with a hole. Like in FIG. 4B, the first section (1421)shows a rapid loss of pressure as the endoscope (901) reaches a stableequilibrium pressure. However, once this equilibrium is reached, theendoscope (901) loss rate decreases in section (1423). However, theendoscope (901) is unable to maintain the pressure because of the holeand while the pressure loss rate is decreased in section (1423), it isstill too high and the endoscope (901) is clearly leaking air.

The three graphs or similar ones can be utilized by the computer controlsystem (301) to provide for more accurate determinations of when thereis a hole which is leading to air loss. In particular, the processor(303) can evaluate the rate of the air loss (slope of the line) todetermine when loss transitions from being due to the endoscope (901)searching for equilibrium pressure, to either loss from a hole ornatural loss simply to be expected even when integrity is still beingmaintained.

To carry out this analysis, the computer control system (301) will firstgenerally recognize that there will be an initial rate of decrease afterthe air enclosure is sealed. It will, therefore, wait until the section(1401), (1411), or (1421) was passed by looking for a leveling of therate. Upon determining that the air pressure is beginning to level out,the system will examine what the current pressure is. If the pressure issufficiently high that the pressure may be maintained and is notindicative of a large hole (FIGS. 5B and 5C), the computer controlsystem will commence the measurement period.

During the measurement period, the system may be examining the rate ofair loss in an instantaneous fashion, or may wait until the end andevaluate the change over time. Regardless of which method is used, therate of decrease of the second section (after sterilization) measuredwill be used to determine if the loss is unacceptably high andindicative of a hole. The rate of loss can take into account specificssuch as the age of the endoscope (901) and other prior tests for loss asdiscussed previously. Generally, such a determination will occur bycomparing the current rate of the air loss after stabilization to aselected maximum allowed rate.

In an embodiment, if an endoscope (901) has a rate of loss on par withthe rate of loss it has on prior tests, that can be indicative that theendoscope's (901) integrity has not been compromised. If the endoscope(901) had been previously evaluated or repaired and was known to nothave any holes at the times of prior tests this context-sensitivedetermination can provide improved accuracy. If the rate has increaseddramatically over prior tests, that can be indicative of a hole and theendoscope (901) can be put aside to be further evaluated. Further,because of the fact that rate of loss, and not raw air loss values arebeing examined, the endoscope (901) can stabilize at different valuesdepending on environmental conditions and testing conditions at the timeof the particular test without the computer control system (301)necessarily being less accurate in its determination.

The ability to compensate for changing environmental or otherconditions, and changes to the endoscope over time, provides parameterselection which is context-sensitive and can help improve accuracy incalculation and detection of scopes which actually are damaged.

The processor (303) will also generally store values in step (814)related to the pressure test in memory in step (814). Generally thesevalues will include the starting and ending pressure readings and thepressure change (which can be calculated by the processor (303) from thestarting and ending pressure or could have been calculated instantly).The pass/fail result will generally also be stored. A clock valuerelated to the time the test took to perform and the time the test wasperformed may also be stored. In an embodiment, additional informationmay be stored (or the addresses of such information may be maintainedfor a longer time) if the endoscope (901) fails than if it passes. Inthis way, diagnostic information related to the failure may be availableto help repair personnel determine the cause of the failure.

Once the integrity tester (10) has determined that the endoscope (901)has passed or failed the pressure test, the next test (humidity test)determines if the endoscope (901) includes any fluid within itsinternals and may provide a double check for holes. The integrity tester(10) may start the humidity test automatically following the conclusionof the pressure test, or may request input from the user about whetherto commence the humidity test in step (851). If the test is to goforward, the humidity test may be performed in a regular or extendedfashion as indicated in step (855). Generally prior to the humiditytest, the processor will determine the baseline humidity in step (853)from the stored values (814). As the air pumped into the endoscope (901)was generally dried by a desiccator prior to entering the endoscope(901) as part of the process, it should still be dry and will generallybe dryer than the outside air. If the system includes a hole, however,the dry air (which was under pressure) will often have escaped out thehole during the pressure test and environmental air will be pulledthrough the hole into the endoscope (901) during the humidity test.Alternatively, liquid may have already entered the endoscope (901) andwill be vaporized by the dry air provided under pressure, providing morehumidity to the air.

The baseline for environmental humidity is generally established as partof the selection of initial variables as discussed above and is pulledfrom memory in step (853). Alternatively, in step (853) the processor(303) may issue queries for the initial values. To test for humidityinside the endoscope (901), air from within the air enclosure, whichincludes the air in the endoscope (901), will be vented into contactwith the humidity sensor in step (857). At the start of the venting, theair inside the air enclosure is generally at higher pressure than anyair in the vent path. If there was little loss of pressure, the air inthe air enclosure will generally push itself to the humidity sensor,however, it is often desired to pull additional air from the airenclosure. In this situation, the software may instruct an airwithdrawing system (which may be the air source operated in reverse inan embodiment) to suck or pull air from inside the air enclosure. Thistype of operation is indicated in step (859) of the extended test shownin FIG. 3. Alternatively, the air source can push air into the airenclosure to create a flow of air through the air enclosure. In such asituation, the processor (303) may continuously monitor the pressure(818) in the air enclosure in step (863) to prevent a positive ornegative pressure situation from potentially damaging endoscope (901)components. The time of performance of the test may be based on simpleventing time from the clock signal (816) as is shown performed in thestandard test in step (861) or may be based on the resultant pressure inthe air enclosure as indicated in step (863) of the extended test. Asshown in the embodiment of FIG. 3, the nature of the air collection maydepend on the type of humidity test desired. In the extended test side,air is purposefully pulled from the endoscope (901). This can bedesirable if it is already known that the endoscope (901) failed thepressure test. Such failure can indicate insufficient air pressureremaining in the air enclosure to get a valuable reading. Therefore, thedifferent test selected may be based on the testing parameters, or maybe selected based on already taken readings.

If there is fluid in the endoscope (901), the fluid will usually be atleast partially vaporized by the pressurized air previously applied andbe pulled into contact with the humidity sensor during the testing. Thehumidity sensor (121) will then register that the humidity level of theair is of a certain level in step (865) following a possible waitperiod. That level is indicated to the processor (303) in step (867)where it is compared with testing parameters. Generally, if this levelis at or above a trigger amount determined from a baseline humidityselected based on the testing parameters and/or environmental readingsas compared in step (867), an indicator of fluid invasion is triggeredin step (869). Alternatively, if the humidity is sufficiently low, thehumidity test is passed in step (871).

While the air provided to the endoscope (901) is essentially dry, it islikely that air previously in the endoscope (901) included some humidityand therefore an amount based on the environmental baseline, instead ofbased on the air having absolute dryness, is preferably used as atrigger. In an alternative embodiment, an absolute dryness level may beused or an independently chosen level of humidity may be selected (suchas that based on the humidity of a dry scope for example). The output ofthe humidity test may be used to indicate fluid invasion of theendoscope (901), as indicated, or may alternatively or additionally be asecondary leak test. In the second instance, a humidity may be detectedwhich may indicate that environmental air is invading the endoscope(901), but no actual fluid is believed to have entered yet.

In a still further embodiment, the computer control system (301) mayutilize a threshold humidity value based on an environmental calculationwhich takes into account changing humidity conditions over time at thetesting location. In this embodiment, the computer control system (301)determines a flexible humidity baseline which is determined based onhumidity results obtained from prior testing runs of the tester (10). Inan embodiment, the testing runs are not for the same endoscope (901)that is currently being tested, but are instead based on an average orother mathematical manipulation of prior runs of all endoscope (901)within a certain time period, or numerical range of testing (e.g. thelast 200 tests). What this will allow the computer control system (301)machine to do is slowly adjust the baseline for changing environmentalconditions as those conditions slowly change at the tester's (10)location.

For example, it is well known that inside buildings, there is generallya decreased humidity during winter months (as furnace systems dry airand there is less water evaporation) than during summer months (whenfurnaces are not active and environmental water evaporation is greater).However, humidity levels do not suddenly shift between winter and summerlevels but will generally slowly oscillate over time.

In operation, the computer control system (301) when opening in anenvironmental compensation mode may operate as indicated by theflowchart of FIG. 6. The computer control system (301) in thisembodiment will begin by determining the change in humidity among alarge number of previous test runs (for instance 200) in step (1601).This calculation may be the humidity of the endoscope's (901) testresults compared to the environmental humidity (the difference inhumidity) or may be a raw humidity calculation from the endoscopes(901). These would generally be both pass and fail runs, however, onlypass or fail runs could be used in an alternative embodiment. Thenumbers will then generally be averaged in step (1603) to provide for acomparison value. In addition to averaging, step (1603) could alsoinclude other mathematical manipulation such as, but not limited to,computing standard deviation or determining other values representativeof the variance in the numbers. The system will then perform thehumidity testing in step (1605) on the current endoscope (901) andcompare in step (1607) the result for the current endoscope (901) to thevalue(s) obtained in step (1603). In the determination step (1609), solong as the humidity value of the current endoscope (901) (whetherabsolute or comparative) is within an area of tolerance based on thiscalculation, the endoscope (901) is passed as indicated by step (1611).A sufficient deviation from the expected value would result in anindication of failure in step (1613). The area of tolerance may alsochange depending on humidity. For instance, if the environmentalhumidity is higher, smaller changes may be triggered as failures as theincreased moisture in the air is more likely to trigger a concern.

While the above focuses on a calculation based in change in humidity,the absolute humidity of the scope may also be used. In particular, thelevel of expected humidity may be determined for a large number ofendoscopes (901) based on recent tests performed by the tester (10).This can be logical as the air fed into the endoscopes (901) isgenerally of a similar controlled humidity level. However, air that maybe pulled into the endoscope (901) through a leak or provided by thetester may include some variance in humidity over time depending onchanges to external humidity or may change in humidity due to absorptionof moisture or other factors having to do with environmental air beinginternal to the endoscope (901) prior to testing. Humidity indicationsabove this context-sensitive value by more than a tolerable amount maytrigger an indication that humidity presence is not due simply to morehumid air being within the endoscope (901), but by aerosolization ofwater internal to the endoscope (901), or humid external air beingpulled in through a hole.

If the humidity is sufficiently low in the tested air, insufficienthumidity is detected and, it is determined by the computer controlsystem (301) that there has been no fluid invasion, or at least notsufficient fluid invasion to generate concern. If humidity testing alsodoes not indicate a hole, the endoscope (901) passes humidity testingand the humidity “pass” result is indicated in step (871) otherwise theendoscope (901) is failed in step (869). These outcomes are displayed tothe user in step (874). Values related to the humidity testing such asthe internal humidity value, environmental humidity value and thedifference in values along with the determination of the control systemregarding pass or fail of the endoscope may again be stored in memory(814) after completion of the test. Once both tests are completed andthe outcomes calculated, the tester (10) has effectively completed thetest process.

In the depicted embodiment, the integrity tester (10) will be attachedto a printer or other hardcopy generator (181). This allows the operatorto print out an indication of what happened during the test (includingpass, fail and other details) to keep with the endoscope (901) or with acentralized records system in step (876). In the event of a failurerequiring repair, the printout can be put with the endoscope (901) andprovided to those responsible for repair.

In an embodiment, the printout is provided automatically and includesthe information that was stored in the memory related to the testing ofthe endoscope (901) just tested. This information will generally beprovided in an easily readable form and may be provided on a paper tape.An embodiment of such a paper tape printout is provided in FIG. 4.

The paper tape (700) includes the information stored for this endoscope(901) and may include the identification information (701) of theendoscope (901). The tape (700) may also include an indication of thelevel of passage or failure (703), if desired, to indicate if theendoscope (901) failed dramatically or only just failed. The tape (700)may also include date and time information (705) along with indicationsof the name and version of the software and/or processor (303) beingused (707) to make sure that if there are any updates which may have notbeen used when the test was done. The tape (700) may also include whichtype of tests were performed.

The tape (700) above simply provides for simple reference informationand will often be placed with the endoscope (901) prior to its next useso that the next user can confirm that the endoscope (901) is ready foruse and has been recently tested. In the event of a failure by theendoscope (901) of one or both tests, additional information may bestored and/or printed by the computer control system (301) to providefor more information. For example, depending on the type of failure(pressure or humidity) and the severity of the failure, the repairtechnician may therefore have more of an idea of what needs to berepaired, or if additional tests need to be performed to determine theexact nature of necessary repair. If a loss of pressure is sudden andrelated specifically to the period where knobs or buttons were beingmanipulated, for example, the printout (700) may make such an indicationso as to provide the repair technician with an indication that theproblem is probably associated with one of those areas. This can alsoprovide for improved repair response by localizing a point to firstexamine.

In the event that the endoscope (901) failed a humidity test, thisinformation can also be provided. In this case, the repair techniciancan know that the endoscope (901) needs to be disassembled and dried.Further, if no pressure loss was detected, but a humidity test wasfailed, repair personnel may perform more exacting pressure tests on theendoscope (901) utilizing more exacting testing parameters to determineif a very small, but important hole, exists, or if a hole may exist inconjunction with a knob movement or button press which was notaccurately detected, for instance if a technician had skipped the stepor only performed it a rudimentary level but indicated it had beenperformed. Alternatively, the technician can test the integrity of capfittings or similar devices to try and locate a possible point of fluidentry that may not necessarily indicate an integrity problem, butinstead simply a misassembled endoscope (901) at some point in time.

In addition or alternatively to providing for a printout (700) oftesting results, the integrity tester (10) may store values in localmemory or may be connected to a computer network such as, but notlimited to, an intranet, extranet, internet, or the Internet so as toact as a client or server on the network. In this situation, theinformation on the specific test need not be stored in local memory butmay be reported to a central data repository. For instance, if anendoscope (901) is indicated as failing, a notice may be sent to repairpersonnel to expect to receive the endoscope (901). Any or all datacollected by the control system (301) during the test may also beforwarded and provided to repair personnel or stored for evaluation in acentral location to determine what may be wrong with the endoscope(901). Such information can also be used to monitor the status of ahospital's, or other user's, stockpile of endoscopes. This can be usedto determine if certain types of endoscopes, or those used by certainindividuals are more likely to require repair.

Such central control can also provide for an additional level of safety.If an endoscope (901) fails the test but is inadvertently returned toservice, it may be the case where the medical personnel using theendoscope (901) will double check that the endoscope (901) has beencleared before using it by entering the serial number again at thestarting point of the medical procedure into a computer on the network.In this situation, the serial number lookup at the central records areawould indicate that the endoscope (901) should not be used and medicalpersonnel can reject it for repairs and obtain a new scope before thereis a possibility of the device harming a patient or from the devicebeing additionally damaged.

While the invention has been disclosed in connection with certainpreferred embodiments, this should not be taken as a limitation to allof the provided details. Modifications and variations of the describedembodiments may be made without departing from the spirit and scope ofthe invention, and other embodiments should be understood to beencompassed in the present disclosure as would be understood by those ofordinary skill in the art.

The invention claimed is:
 1. A method for testing the integrity of anendoscope comprising the steps of: obtaining an endoscope to be tested;supplying gas to an air enclosure which includes an internal volume ofsaid endoscope to pressurize said air enclosure; measuring the pressureof said gas in said air enclosure over time instructing a user tomanipulate said endoscope using a computer control system while said airenclosure is pressurized, said manipulation causing movement of saidendoscope; instructing the user to indicate to said computer controlsystem that said manipulation of said endoscope is complete;re-measuring the pressure of said air enclosure after said manipulationis complete to indicate a presence of a leak in said endoscope;retrieving a plurality of calibrating humidity values from a pluralityof prior endoscope tests from a memory; obtaining an environmentalhumidity value from air external to said endoscope to be tested;manipulating at least a portion of the combination of said plurality ofcalibrating humidity values and said environmental value to produce atarget humidity value; venting said gas in said air enclosure to ahumidity detector; determining the level of humidity in said vented gas;and comparing said level of humidity to said target humidity value todetermine if said level of humidity in said endoscope is sufficientlyhigh to indicate fluid invasion into said endoscope to be tested.
 2. Themethod of claim 1 wherein in said retrieving, said plurality of priortests do not include a prior test of said endoscope to be tested.
 3. Themethod of claim 1 wherein in said retrieving, said plurality of priortests only include prior tests of said endoscope to be tested.
 4. Themethod of claim 1 wherein in said manipulating, an average ofcalibrating humidity values is determined.
 5. The method of claim 1wherein in said manipulating a weighted average of calibrating humidityvalues is determined using said environmental humidity value as theweighting factor.
 6. A computer implemented method for performingendoscope integrity testing, the method comprising: providing to acomputer controlled endoscope tester an endoscope to be tested; thecomputer controlled endoscope tester capable of: supplying air to an airenclosure which includes an internal volume of said endoscope to test afirst property of air within the enclosure; sealing said air enclosure;measuring said first property of air in said air enclosure over time;indicating to a user to manipulate said endoscope while said airenclosure is sealed, said manipulation causing movement of saidendoscope, and instructing the user to indicate when said manipulationof said endoscope is complete; re-measuring said first property of saidair enclosure after said manipulation is complete; said testeridentifying said endoscope as having been tested previously; said testerretrieving from a memory, a retrieved value of a second property of airdetermined from at least one prior test of said endoscope; said testerdetermining a current value of said second property of air from said airsupplied into said internal enclosure of said endoscope; said testercomparing said current value to said retrieved value; said testerdetermining if said comparison indicates a compromise of integrity insaid endoscope; and said tester supplying said determination to theuser.
 7. The method of claim 6 wherein said retrieved value is anaverage of all prior tests of said endoscope.
 8. The method of claim 6wherein said first property of air is pressure.
 9. The method of claim 6wherein said second property of air is humidity.
 10. The method of claim6 wherein said identifying includes, identifying a serial numberassociated with said endoscope.
 11. The method of claim 6 furthercomprising: recording said current value.
 12. A computer system fortesting endoscopes, the system comprising: at least one sensing means;memory means; and processing means coupled to said sensing means andsaid memory means; said processing means being capable of causing thecomputer system to: supply air to an internal enclosure which includesan internal volume of an endoscope to test a first property of airwithin the enclosure; seal said air enclosure; measure said firstproperty of air in said air enclosure over time; instruct a user tomanipulate said endoscope while said air enclosure is pressurized andinstruct the user to indicate that manipulation of the endoscope iscomplete, said manipulation causing movement of said endoscope;re-measure said first property of said air enclosure after saidmanipulation is complete; identify said endoscope to be tested as havingbeen tested previously; retrieve from said memory, a retrieved value ofa second property of air determined from at least one prior test of saidendoscope; determine a current value of said second property of air fromsaid air supplied into said internal enclosure of said endoscope;compare said current value to said retrieved value; determine if saidcomparison indicates a compromise of integrity in said endoscope; andsupply said determination to the user.
 13. The method of claim 1,wherein said retrieving of the plurality of calibrating humidity valuesis performed if said endoscope does not have a pressure leak.
 14. Themethod of claim 1, wherein said retrieving of the plurality ofcalibrating humidity values is performed if said endoscope has apressure leak.
 15. The method of claim 1, wherein the gas is air.